EP2664356A1

EP2664356A1 - System for neuropathic pain rehabilitation

Info

Publication number: EP2664356A1
Application number: EP20120380025
Authority: EP
Inventors: Maria Dolors Soler Fernandez; Eloy Opisso Salleras
Original assignee: Fundacio Privada Institut de Neurorehabilitacio Guttmann
Current assignee: FUNDACIO INSTITUT GUTTMANN
Priority date: 2012-05-18
Filing date: 2012-05-18
Publication date: 2013-11-20
Anticipated expiration: 2032-05-18
Also published as: EP2664356B1; PL2664356T3; ES2555225T3

Abstract

The system use a (tDCS) apparatus with a cap sized to fit over a portion of a patient's head; connecting points for electrodes operatively associated with an inner surface of the cap and a power supply in electrical communication with the electrodes and with a control interface, the system further comprising:
- a computer device with a dedicated software and an associated control unit to provide a patient's self operation of said tDCS apparatus
- at least a camera to capture at least a partial image of said patient; and

a screen to present to said patient a combination of said partial patient's own image and a complementary image provided by an animated digital image representative of a movement of a body injured part of the patient capable of generating a visual illusion suitable to correct mismatching between motor commands and sensory feedback.

Description

Field of the art

The present invention generally relates to a system that includes a transcranial direct current stimulation apparatus designed to be used by a patient at a place remote from a clinic location, i.e. allowing a home self-treatment of a neuropathic pain, under assistance of a computer device that guides and controls the correctness ad safety of the treatment, the system allowing a remote connection to a clinic station for further guidance or correction.
The invention also provides a method to use the system comprising providing, to a patient suffering from said neuropathic pain, a visual illusion to correct a mismatch between motor commands and sensory feedback, and more particularly to a method further comprising applying a direct cranial stimulation to said patient during at least part of the duration of said visual illusion.
The method of the invention is particularly applicable to patients suffering from spinal cord injuries.

Prior State of the Art

Neuropathic pain affects ∼40% of patients following spinal cord injury (SCI) (Siddall et al., 2003; Widerström-Noga and Turk, 2003; Soler et al., 2007) and represents a highly disabling clinical condition. The injured spinal somatosensory circuitry is thought to generate aberrant nocioceptive impulses that are interpreted by the brain as pain (Yezierski, 2005). Thalamic integrative circuits may also act as generators and amplifiers of nocioceptive signals (Hains et al., 2005, Waxman and Haines, 2006). Sensory deafferentation after SCI induces profound and long-lasting reorganization of the cortical and subcortical sensory maps in the adult brain (Lotze et al., 2006; Kokotilo et al., 2009; Wrigley et al., 2009). Pathophysiological consequences of such cortical plasticity may underlie the development of phantom sensations and pain (Moore et al., 2000; Lotze et al., 2001; Wrigley et al., 2009; Soler et al., 2010). Strategies aimed at reversing or modulating the somatosensory neural reorganization after injury may be valuable alternative therapeutic approaches to neuropathic pain.
Examples of such approaches that have shown some promise for the treatment of neuropathic pain following SCI or limb amputation include the use of movement imagery (Gustin et al., 2008; Maclver et al., 2008), mirror therapy (Ramachandran and Hirstein, 1998; Giraux and Sirigu, 2003; Chan et al., 2007) or 'virtual' mirror therapy (Moseley, 2007). Long-term pain relief was achieved by repeated treatment sessions in which patients were given the visual illusion that they could move and use again their deafferented or missing limbs. Pain relief presumably involves correction of the incongruence between motor output and sensory feedback, and normalization of cortical somatosensory representation maps, induced by the visual input of movements of the paralysed/missing limbs (Ramachandran and Rogers-Ramachandran, 1996; Harris, 1999; Moseley, 2007). Mirror therapy may also contribute to modulate cortical and spinal excitability (Giraux and Sirigu, 2003; Stinear and Byblow, 2004; Garry et al., 2005; Funase et al., 2007; Sakamoto et al., 2009).
W02009/137683 discloses a transcranial direct current stimulation apparatus and method that includes the features of the preamble of claim 1.
US patent application 12/197,883 of the same applicants refer to a method for treating neuropathic pain, designed to be implemented at a clinical site, comprising, provide to a patient suffering from said neuropathic pain, a visual illusion to correct a mismatch between motor commands and sensory feedback and applying a transcranial direct current stimulation to said patient during at least part of the duration of said visual illusion.
WO 2007/138598 discloses a method of rehabilitation management involving brain stimulation, comprising: providing a plurality of patients fitted with sensor; assigning task to said patients by a therapist; rehabilitating said patients not under the direct attention of said therapist and monitoring the rehabilitating using data acquired by the sensors during performance of the tasks.
The current invention provides a similar rehabilitation treatment as disclosed in US 12/197,883 but implemented at home under self-control of the patient while remote complementary assistance is foreseen.

Summary of the invention

Thereby the present invention proposes a system for neuropathic pain rehabilitation, including as already known in the art.
a transcranial direct current stimulation (tDCS) apparatus comprising:

a cap sized to fit over a portion of a patient's head;
two or more connecting points for electrodes operatively associated with an inner surface of the cap; and
a power supply in electrical communication with the electrodes and with a control interface both said power supply and said control interface being sized to be worn by and transported by a patient in use,
and the system as per this invention further comprises:
- a computer device on which a dedicated software runs and an associated control unit to provide a patient's self operation of said tDCS apparatus acting through said control interface during a neuropathic pain rehabilitation session initiated by said patient.;
- at least a camera to capture at least a partial image of said patient;
- a screen to present to said patient a combination of said partial patient's own image and a complementary image consisting in an animated digital image representative of a movement of a body injured part of the patient capable of generating a visual illusion suitable to correct mismatching between motor commands and sensory feedback, said combination of images being prepared or generated under control of said dedicated software and computer device.

Each of the cited electrodes comprises a non invasive electrode pad and attachment member providing for the selective placement of the electrode at more than one possible position on the inner surface of the cap where a complementary attachment member and electrical connection exists.
Moreover the computer device comprises a net connection to a remote medical centre that can evaluate o supervise any of said patients sessions and provide to said patient complementary operating instructions.
Meanwhile the control interface includes an electronic circuit with a wireless communication unit allowing at least a communication with said computer device.
According to a preferred embodiment both of the control interface and the power supply are associated to the cap.
The control interface of the tDCS includes means for a checking of:

impedance of each of the connecting sections from each of the electrodes to the power source; and
polarity of each of the electrodes;

The control interface of the tDCS includes also means for further managing:

duration and conditions of feeding of said electrical current that is a DC current;
projection on the screen; and
capture of the person's image or part thereof.

The invention in a second aspect provides a method for neuropathic pain rehabilitation by a tDCS treatment comprising following steps:

providing a patient with a tDCS apparatus at a location remote from a clinic location, said tDCS apparatus comprising as previously disclosed a cap sized to fit over a portion of a patient's head; two or more electrodes operatively associated with an inner surface of the cap and a power supply in electrical communication with the electrodes and with a control interface both said power supply and said interface being sized to be worn by and transported by a patient in use;
initiating tDCS treatment at a remote location away from the clinic location under a guidance of a computer device connected to said tDCS allowing said patient a self operation of said tDCS apparatus;
presenting in a screen to said patient a combination of a partial own image captured by a camera and a complementary image provided by an animated digital image representative of a movement of a body injured part of the patient capable of generating a visual illusion suitable to correct mismatching between motor commands and sensory feedback; and
controlling said combination of images being provided by said computer device in communication with said patient, the computer device also providing instructions about activity of the patient.

The method of this invention further includes guidance from a remote clinic station of any pain rehabilitation session by remote connection to said computer device.
The digital image can include augmented reality components to enhance perception and truth o plausibility of the represented movement of a body member o body part.
Other features of the invention will be apparent from the following description of one embodiment thereof.

Brief description of the drawings

Fig. 1 is a perspective view showing the local scenario where the invention is implemented.
Fig. 2 is a diagram that discloses the architecture of the control interface and elements of the disclosed system related in order to implement the invention.

Detailed description of embodiments of the invention

Fig. 1 discloses a patient 10, wearing a cap 11 for a transcranial direct current stimulation (tDCS), and a computer device 12 with a dedicated software related to an associated control unit (not illustrated) to provide to the patient a self operation of said tDCS , acting through a control interface (see Fig. 2) during a neuropathic pain rehabilitation session initiated by said patient.
As well known the cap 11 includes two or two or more connecting points for electrodes operatively associated with an inner surface of the cap, and a power supply in electrical communication with the electrodes and with a control interface 15 (Fig. 2) both said power supply and said control interface being sized to be worn by and transported by a patient in use.
Each of the electrodes comprises a non invasive electrode pad with and attachment member providing for the selective placement of the electrode at more than one possible position on the inner surface of the cap where a complementary attachment member and electrical connection exists. Each of said electrodes comprises for a suitable use a sponge with a contact surface area structured to provide for contact with a patient's scalp.
The system according to the invention includes a camera 13 to capture a partial image of the patient 10 and a screen to present to said patient 10 a combination of said partial patient's own image and a complementary image provided by an animated digital image representative of a movement of a body injured part of the patient, in such a way the combined image is capable of generating a visual illusion suitable to correct mismatching between motor commands and sensory feedback, said combination of images being prepared or generated under control of said computer device 12 and dedicated software running on it.
The screen 14 can be provided by the own computer device 12 or by an auxiliary screen as in the Fig. 1.
The computer device 12 include a net connection that provide in operation a connection to a remote medical centre that can evaluate o supervise any of said patients sessions and provide to said patient complementary operating instructions.
As to the control interface 15 it comprises an electronic circuit with a wireless communication unit allowing a reliable communication with said computer device 12
In a preferred embodiment both of the control interface 15 and the power supply are associated to the cap 11. For example the power supply comprises one or more batteries attached to the cap and the control interface 15 can also be attached to the cap.
As detailed in Fig. 2 the control interface 15 of the tDCS comprises means for a checking of:

impedance (Ω) of each of the connecting sections from each of the electrodes to the power source; and
polarity of each of the electrodes;

The control interface 15 of the tDCS further includes means for further managing:

duration and conditions of feeding of said electrical current that is a DC current (the selected current level is provided through DC pulses under a width control);
control of the digital image on the screen; and
capture of the person's image or part thereof.

According to a preferred implementation of the system and method of this invention the selected current level is initially provided according to an up current ramp having a selected duration and current application is terminated according to a down current ramp having a selected duration.

Claims

System for neuropathic pain rehabilitation, including:
a transcranial direct current stimulation (tDCS) apparatus comprising:
- a cap sized to fit over a portion of a patient's head;

- two or more connecting points for electrodes operatively associated with an inner surface of the cap; and

- a power supply in electrical communication with the electrodes and with a control interface both said power supply and said control interface being sized to be worn by and transported by a patient in use;

characterized in that it further comprises:
a computer device with a dedicated software and an associated control unit to provide a patient's self operation of said tDCS apparatus acting through said control interface during a neuropathic pain rehabilitation session initiated by said patient.;

at least a camera to capture at least a partial image of said patient;

a screen to present to said patient a combination of said partial patient's own image and a complementary image provided by an animated digital image representative of a movement of a body injured part of the patient capable of generating a visual illusion suitable to correct mismatching between motor commands and sensory feedback, said combination of images being prepared or generated under control of said computer device and dedicated software.
System, according to claim 1, characterized in that said computer device comprises a net connection to a remote medical centre that can evaluate o supervise any of said patients sessions and provide to said patient complementary operating instructions.
System according to claim 1, wherein said control interface including an electronic circuit with a wireless communication unit allowing at least a communication with said computer device.
System according to claim 1, wherein both of said control interface and said power supply are associated to said cap.
System according to claim 1, wherein each of said electrodes comprises a non invasive electrode pad with and attachment member providing for the selective placement of the electrode at more than one possible position on the inner surface of the cap where a complementary attachment member and electrical connection exists.
System according to claim 1 wherein said control interface of the tDCS comprises means for a checking of:
• impedance of each of the connecting sections from each of the electrodes to the power source; and

• polarity of each of the electrodes;
acting as a security measure to confirm right positioning of the electrodes and feed current.
System according to claim 6 wherein said control interface of the tDCS includes means for further managing:
• duration and conditions of feeding of said electrical current that is a DC current;

• projection on the screen; and

• capture of the person's image or part thereof.
System according to claim 7 wherein the selected current level is provided through DC pulses under a width control.
System according to claim 7 wherein the selected current level is initially provided according to an up current ramp having a selected duration and current application is terminated according to a down current ramp having a selected duration.
System according to claim 1, wherein each of said electrodes comprises a sponge with a contact surface area structured to provide for contact with a patient's scalp.
System ac cording to claim 4 wherein said power supply comprises one or more batteries attached to the cap.
System according to claim 1, wherein said control interface is attached to the cap.
System according to claim 1, wherein said screen is provided by said computer device or by an auxiliary screen.
A method for neuropathic pain rehabilitation by a tDCS treatment comprising:
providing a patient with a tDCS apparatus at a location remote from a clinic location, said tDCS apparatus comprising a cap sized to fit over a portion of a patient's head; two or more electrodes operatively associated with an inner surface of the cap and a power supply in electrical communication with the electrodes and with a control interface both said power supply and said control interface being sized to be worn by and transported by a patient in use, and

initiating tDCS treatment at a remote location away from the clinic location under a guidance of a computer device connected to said tDCS allowing said patient a self operation of said tDCS apparatus, and

presenting in a screen to said patient a combination of a partial own image captured by a camera and a complementary image provided by an animated digital image representative of a movement of a body injured part of the patient capable of generating a visual illusion suitable to correct mismatching between motor commands and sensory feedback,

controlling said combination of images being provided by said computer device in communication with said patient, said computer device also providing instructions about activity of the patient.
A method according to claim 14, and further comprising guidance from a remote clinic station of any pain rehabilitation session by remote connection to said computer device
A method according to claim 14, and wherein said digital image includes augmented reality components.